Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00115687 · ClinicalTrials.gov registry record · Phase 2
Nicotine Replacement Treatment for Pregnant Smokers - 1
A Phase 2 study, sponsored by National Institute on Drug Abuse (NIDA).
- Terminated
- Registry status
- Phase 2
- Development phase
- 250
- Enrollment target
NCT00115687: Clinical Trial Phase 2 study, sponsored by National Institute on Drug Abuse (NIDA).
NCT00115687 is a Phase 2 study that was terminated before completion, run by National Institute on Drug Abuse (NIDA). The registered enrollment target is 250 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (88% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00115687, a Phase 2 study, was terminated before completion, sponsored by National Institute on Drug Abuse (NIDA).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 250 participants
- Enrollment target
Study Summary
Smoking during pregnancy is an important modifiable cause of poor pregnancy outcomes. Even with augmented behavioral interventions, smoking cessation rates in pregnancy trials rarely exceed 20%. These low quit rates may be due to inadequate treatment of the physical dependence on nicotine. Indeed, medications, which may help to reduce nicotine withdrawal symptoms, are a first-line treatment for smoking treatment in non-pregnant smokers. However, little information is available on the safety or efficacy of medications to treat pregnant smokers. The purpose of this trial is to evaluate the safety and effectiveness of 2 mg nicotine gum in promoting smoking cessation during pregnancy. The design is a randomized, placebo controlled trial where subjects are randomized to nicotine gum (6 weeks ad libitum use followed by a 6 week taper) or a matching placebo. Women who are doing well at the end of the trial will also be offered gum post-partum for relapse prevention.
Interventions
- DRUG placebo
- DRUG 2 mg nicotine polacrilex
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2002-06 |
| Est. Completion | 2007-04 |
| Phase | Phase 2 |
Why NCT00115687 stopped before completion
NCT00115687 is an interventional study that assigns participants to a tested intervention. The registered 250 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (88% higher).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00115687 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00115687 about?
NCT00115687 is a clinical study titled "Nicotine Replacement Treatment for Pregnant Smokers - 1". Smoking during pregnancy is an important modifiable cause of poor pregnancy outcomes. Even with augmented behavioral interventions, smoking cessation rates in pregnancy trials rarely exceed 20%. These low quit rates may be due to inadequate treatment of the physical dependence on nicotine. Indeed, m...
What is the current status of trial NCT00115687?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 250 participants. The study started on 2002-06. Estimated completion is 2007-04.
What interventions are being tested in trial NCT00115687?
The interventions under investigation include: placebo (DRUG), 2 mg nicotine polacrilex (DRUG).
Who is sponsoring clinical trial NCT00115687?
This trial is sponsored by National Institute on Drug Abuse (NIDA), which has 335 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00115687's enrollment target sits among peer trials
250 222nd of 2000 higher than 1,768 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00483249 · 250 participants · NA
Endovascular Exclusion of Thoracoabdominal and/or Paravisceral Abdominal Aortic Aneurysm
- NCT00777712 · 250 participants
Mechanisms Underlying Impaired Diabetic Wound Healing
- NCT01451502 · 250 participants · NA
Infusion of Cell Populations From Unlicensed Umbilical Cord Blood Units
- NCT01771718 · 250 participants
Pilot Study on In-vivo Non-invasive Skin Imaging Using Multiphoton Microscopy
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia